FDA at the Center of Huge Gray Area in Establishing Regs for Wireless Health, Execs Say

When Rob McCray founded San Diego’s Wireless Life Sciences Alliance (WLSA) in 2005, the group’s corporate membership constituted just three companies: Qualcomm; Johnson & Johnson; and TripleTree, a boutique banking and research firm where McCray was a partner.

Since then, the convergence of healthcare and wireless technologies has become more obvious, and the WLSA has expanded to 65 dues-paying members, including life sciences companies like Sanofi, health services providers like OptumHealth, and consumer products companies like Procter & Gamble. Under McCray, who is now CEO, the WLSA also has evolved from a volunteer group into a more professional organization that recently hired Molly Cogan as executive director, with responsibility for overseeing conferences and other events.

“We’re structured as a nonprofit trade association, but our mission really is to create better access to affordable healthcare,” McCray says. Combining the power of wireless devices, smartphones, and tablets with medical care represents a technology revolution that’s potentially as powerful as the Internet itself, but as McCray adds, “you have to come up with products, services, and apps that are effective and safe.”

And therein lies the rub.

Rob McCray

As the FDA asserted its regulatory authority over wireless health, a wave of innovation now underway has come under a cloud of uncertainty. On July 21, the FDA issued its draft guidance for regulating mobile health, and the agency has been gathering public comment since then about its proposed regulatory scheme. That process is scheduled to continue until Oct. 19, and it will likely take the agency a year after that to finalize its draft guidelines and issue formal regulations, according to Russell Fox, who tracks such regulatory issues in Washington D.C. for the Mintz Levin law firm.

“What the FDA is going to do in wireless health and mobile is the top factor in what investors are going to do,” McCray says. “The FDA is the first topic to come to mind for them.”

McCray says he views wireless health as a wave of healthcare-related technologies that is building at a time of huge growth driven by the aging of the baby boom generation. When medicine usually adopts new technology, the effect has been to increase the cost of healthcare, McCray adds. Yet the advent of information technologies and consumer electronics represent a way to potentially realize tremendous cost savings in medical care.

“The FDA is right in the center of that now,” McCray says. “The FDA is struggling with these issues. They’re supposed to filter products that individuals or patients can’t, because they’re too complex. So they’re trying to evaluate for safety and efficacy.”

The significance of this process in San Diego was evident this morning, as nearly 60 people attended an early morning briefing on the proposed guidelines that included a “Town Hall” conference call with Bakul Patel, policy advisor at the FDA’s Center for Devices and Radiological Health

“People who are in medical devices sector understand that the FDA is a process,” McCray told me earlier. “The issue with wireless health is that we don’t have a track record because it is so new—so that’s where the uncertainty comes from.”

Fox summarized the FDA’s draft guidance before the conference call began. He said the agency plans to assert its regulatory authority over any wireless medical devices or accessories created to control or operate existing medical devices—an electrocardiogram or blood pressure monitor, for example—as well as any mobile apps that transform a smartphone or tablet into a diagnostic or monitoring device that a doctor would use in prescribing patient therapies or in making clinical decisions. The agency does not plan on covering devices that merely record general health information or maintain compendiums of medical information, such as a Physicians Desk Reference.

It soon became clear, however, that an enormous gray area exists in the distinction the FDA wants to draw between wireless devices developed for medical use (which would be regulated) and devices intended for consumer health or fitness (which would go unregulated).

A key factor for the FDA, Fox says, focuses on the manufacturer’s intended use for a particular device and whether it is being used to provide some level of clinical support. A corollary lies in the claims a manufacturer makes about a wireless device, and how the device is promoted or marketed to the public. A device that claims to cure, mitigate, or monitor disease would fall under the FDA’s regulatory purview.

The complexity of the problem, however, became apparent with the first question, when Jim Moon, the chief technology officer for San Diego’s Sotera Wireless, asked: “If I have Apple’s Snow Leopard operating system on my mobile device [with an FDA-approved mobile app], and I upgrade to Lion [Apple’s newest operating system], is that going to invalidate my FDA approval for that app?”

Deepening the uncertainty, John Dobak, a founder and director at San Diego-based Lithera and the former founder and CEO of San Diego’s Innercool Therapies, said a wireless scale used to measure body weight could also be used to monitor a patient for heart failure. “Where is the predicate that changes a weight scale used for fitness to a diagnostic for heart failure?” Dobak asked.

“The FDA is in an environment where they are just not going to be able to control everything,” Fox said. “They’re not going to be able to keep up with the pace of technological advancements.” Still, the agency needs to develop guidelines that make sense in terms of safety and effectiveness.

As McCray put it, the FDA is struggling with these issues.

Bruce V. Bigelow was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Follow @bvbigelow

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